Integrated, peripheral vascular diagnostic system and method therefor

ABSTRACT

The integrated peripheral vascular diagnostic system electronically links a pulse volume recorder PVR, an ocular pneumoplethysmograph OPG, a photoplethysmograph PPG, an audio-frequency analyzer AA unit which characterizes blood flow with a sensitive microphone, and a doppler ultrasound unit. This diagnostic equipment generates data signals. These data signals are converted into digital data signals and are stored in a database. The diagnostic system includes a computer with a processor, a memory, a keypad input device, a display monitor, a printer and an interface for connecting these electronic components together along with an interface for the PVR, OPG, PPG, AA and doppler ultrasound. The diagnostic system further includes a report generator which generates, displays and prints a plurality of vascular diagnostic reports from the digital instrument data signals and the keypad entry data. The diagnostic system also includes, in a further embodiment, an audio playback device such that the technician, when preparing the vascular diagnostic report, can listen to analog versions of the digital instrument data signals. The method for electronically integrating the vascular diagnostic system includes electronically obtaining and converting the instrument data signals into digital data signals, inputting keypad entry data representing manually acquired vascular medical data from the patient, compiling the digital data and the keypad entry data into a database and generating, displaying and printing a plurality of vascular diagnostic reports.

This is a continuation of U.S. patent application Ser. No. 08/968,910filed Nov. 6, 1997, which is now U.S. Pat. No. 6,017,307, which was acontinuation of Ser. No. 08/662,438, filed Jun. 10, 1996, now abandoned,which was a regular patent application based upon provisional patentapplication Ser. No. 60/018,784 filed May 31, 1996.

This is a regular patent application based upon provisional patentapplication, Serial No. 60/018,784, filed May 31, 1996.

The present invention relates to an integrated, peripheral vasculardiagnostic system which electronically links several vascular diagnosticmedical equipment, and a method therefor.

BACKGROUND OF THE INVENTION

In general terms, if a patient presents initially with peripheralvascular disease, there is about a 90% chance that the patient also hascoronary artery disease. On the other hand, if the patient initiallypresents with coronary artery disease, 10% of those patients have someevidence of peripheral vascular disease. In general, coronary arterydisease generally presents itself in a patient earlier in life than doesperipheral vascular disease, and both are manifestations of theatherosclerotic process.

Over the last decade, there has been a steady decline in cardiacmorbidity and mortality. This is due to many reasons, including betterrisk factor control (reduction in smoking), the availability ofanti-arrhythmic drugs, beta blocking drugs, calcium channel blockingdrugs, and coronary bypass surgery. During this same period of time,there has been no tremendous scientific breakthroughs in the generalizedatherosclerotic process.

As a result of the foregoing factors, there is a reasonable segment ofthe population who would have died of coronary artery disease, but nowthose patients live to present with peripheral vascular disease. Inaddition, over the past decade, there has been a sizeable increase inthe number of people over 55 years of age and those people are generallyclassified as being "at risk" for peripheral vascular disease.

A wide range of physicians may deal with some type of vascular analysis.For example, general and family medicine physicians may study extremitysymptoms and cerebral symptoms; cardiologists may study extremitysystems, cerebral systems, and determine the degree of atherosclerosis;vascular surgeons are involved in extremity reconstruction,extra-cranial arterial disease and others; neurologists are involved inthe study of cerebrovascular disease; radiologists are involved ininterventions such as angioplasty, planing, and handling complications;orthopedics are involved in amputation healing and post-operative deepvenous thrombosis (DVT); dermatologists are concerned about lesionhealing; podiatrists are concerned about lesion healing and clearancefor foot surgery; urologists are involved in the study of maleimpotence; obstetricians are involved in the study of deep venousthrombosis (DVT) and ophthalmologists study retinal emboli.

The most common evaluations in a vascular lab fall into threecategories. First, there is evaluation of the arteries that supply bloodto the lower body extremities of the patient. When an occlusion occursin this area, the symptoms may range from resting foot pain, to thedevelopment of ulcers due to lack of blood flow, to pain only whenwalking. Further, vascular laboratories are sometimes requested todetermine the presence or absence of thrombosis of the deep venoussystem in the lower extremities. Thirdly, these vascular laboratoryfacilities evaluate the degree of carotid artery disease. The carotidartery supplies the brain with blood and, when diseased, is a majorcause of cerebrovascular accidents (i.e., stroke). Miscellaneous studiesat vascular laboratories involve the study of upper extremities,compression syndromes, and male impotency (MI) studies.

Currently, there are pulse volume recorders available to study the upperand lower extremities of a patient. Such a study correlates the amountof blood flowing beneath a pressure cuff with each heartbeat of thepatient. Bi-directional continuous wave ultrasound doppler probes areutilized to detect the movement and direction of blood flow througharteries and veins. Audio-frequency analyzer (AA) units are utilized bytechnicians and physicians to listen to and characterize the blood flowvia a sensitive microphone. This involves an analysis of the audiosignals. Ocular pneumoplethysmographs (OPG) are utilized to measure theophthalmic artery pressure in the eyes of a patient.Photoplethysmographs (PPG) are used to monitor blood flow for histolicpressure measurements, venous reflux testing, and arterial blood flow.One example of bi-directional continuous wave ultrasound doppler systemis manufactured by Hokanson as Model MD6. An OPG is manufactured byElectro-Diagnostic Instruments (EDI) as Model OPG-5D. AN PPG ismanufactured by Hokanson, Model MD6RP.

In the past, all these instruments have been used independently to studythe vascular system of a patient.

OBJECTS OF THE INVENTION

It is an object of the present invention to provide an integratedperipheral vascular diagnostic system and a method therefor.

It is a further object of the present invention to provide an integratedvascular diagnostic system which electronically links severalnon-invasive vascular diagnostic equipment such as a pulse volumerecorder or PVR, an ocular pneumoplethysmograph (OPG), aphotoplethysomograph (PPG), an audio-frequency analysis (AA) unit and/ora doppler ultrasound unit.

It is an additional object of the present invention to accept electronicdata signals from one or more of these instruments, to compile theinformation into a database and to generate reports which provide ananalysis of the vascular information collected from the patient as wellas analog representations of the digital data corresponding to theinstrument data obtained from the medical instruments.

It is a further object of the present invention to provide a playbackunit such that the technician analyzing and compiling the vasculardiagnostic report can, simultaneous with the preparation of theelectronic vascular report, listen to analog representations of theultrasound doppler and the audio-frequency AA analysis signals.

It is an additional object of the present invention to be able tocombine the keypad entry data with the instrument data in the databaseand transmit that information to other computer systems for furtherstudy and analysis of the vascular data.

It is another object of the present invention to provide a method forintegrating a vascular diagnostic system with those non-invasivevascular medical devices.

SUMMARY OF THE INVENTION

The integrated peripheral vascular diagnostic system electronicallylinks a pulse volume recorder PVR, an ocular pneumoplethysmograph OPG, aphotoplethysmograph PPG, an audio-frequency analyzer AA unit whichcharacterizes blood flow with a sensitive microphone, and a dopplerultrasound unit. This diagnostic equipment generates data signals. Thesedata signals are converted into digital data signals and are stored in adatabase. The diagnostic system includes a computer with a processor, amemory, a keypad input device, a display monitor, a printer and aninterface for connecting these electronic components together along withan interface for the PVR, OPG, PPG, AA and doppler ultrasound. Thediagnostic system further includes a report generator which generates,displays and prints a plurality of vascular diagnostic reports from thedigital instrument data signals and the keypad entry data. Thediagnostic system also includes, in a further embodiment, an audioplayback device such that the technician, when preparing the vasculardiagnostic report, can listen to analog versions of the digitalinstrument data signals. The method for electronically integrating thevascular diagnostic system includes electronically obtaining andconverting the instrument data signals into digital data signals,inputting keypad entry data representing manually acquired vascularmedical data from the patient, compiling the digital data and the keypadentry data into a database and generating, displaying and printing aplurality of vascular diagnostic reports.

BRIEF DESCRIPTION OF THE DRAWINGS

Further objects and advantages of the present invention can be found inthe detailed description of the preferred embodiments when taken inconjunction with the accompanying drawings in which:

FIG. 1 diagrammatically illustrates one embodiment of the integratedperipheral vascular diagnostic system which includes an examination unit(EU) and an analyzing unit (AU);

FIG. 2 diagrammatically illustrates a cuff tube umbilical unit whichprovides quick connection between the pressure tube ports and the cuffsplaced on the patient during a vascular study;

FIG. 3 diagrammatically illustrates the test port panel for pressuretubes, electrical connections and the remote control device;

FIG. 4 diagrammatically illustrates a pneumatic schematic for the valvesystem for the internally calibrated PVR (ICPVR);

FIG. 5 diagrammatically illustrates the remote control device RCD usedby the operator/technician during the vascular studies;

FIG. 6 diagrammatically illustrates a hardware diagram showing, amongother things, electronic devices in accordance with one embodiment ofthe present invention;

FIG. 7 diagrammatically illustrates the electronic interconnection ofvarious medical devices with the peripheral vascular lab (PVL)input/output (I/O) board and computer system in the examination unit;

FIGS. 8A, 8B and 8C diagrammatically illustrate three embodiments of theinternally calibrated PVR;

FIG. 9 diagrammatically illustrates a flow chart for the analyzing unitmain program;

FIG. 10 diagrammatically illustrates two screen displays which arepresented to the technician at the analyzing unit;

FIG. 11 diagrammatically illustrates a top level flow chart for theoperation of the examining unit program;

FIG. 12 diagrammatically illustrates a general flow chart for thegenerate report program;

FIG. 13 diagrammatically illustrates a flow chart for the review reportprogram;

FIG. 14 diagrammatically illustrates an entity relationship diagram forthe peripheral vascular diagnostic lab and system;

FIGS. 15-39 illustrate exemplary vascular diagnostic reports prepared bythe report generator as part of the diagnostic system; and

FIG. 40 diagrammatically illustrates another embodiment of the presentinvention wherein the integrated peripheral vascular diagnostic systemutilizes a single computer and is placed on a cart.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to an integrated peripheral vasculardiagnostic system and a method therefor.

FIG. 1 diagrammatically illustrates the vascular diagnostic system asincluding an examination unit 10 and an analyzing unit 12. Both unitsinclude computer systems and these computer systems are electronicallylinked together via cable 14. A local area network or LAN permits theelectronic communication and sharing of information between the computer16 in analyzing unit 12 and the computer installed internally within theexamination unit 10.

Examination unit 10 includes a flat screen monitor 17 which is hung onmovable support pole and arm system 19 above table surface 21. Duringthe vascular examination, the technician is prompted to conduct certainvascular tests or examinations based upon instructions presented onflying display monitor 17. Since display monitor 17 can be moved in thex, y and z directions due to the rotational, transverse and translationof supporting arm system 19, flying monitor 17 can be moved out of theway of patient 23.

One type of vascular examination involves the use of an ocularpneumoplethysmograph OPG 25. OPG 25 is also suspended above examinationtable surface 21 on supporting arm system 27. OPG 25 can be rotated,translated and moved transversely away from examination table top 21.

In order to conduct several vascular examinations on patient 23, thetechnician snugly places one or more pressure cuffs 31, 33 on the legsor arms of patient 23. The technician initiates, with the propercontrols on remote control device 41, a sequential increase of pressurein cuffs 31, 33. Pressure sensors in the closed pneumatic system sensethe flow of blood in the patient's vascular system. This is commonlyidentified with the use of pulse volume recorders or PVRs. In order topump up and sense the change in blood flow via the change in pressure inthe closed pneumatic system, pressure cuffs 31, 33 are pneumaticallylinked to a pump and pressure sensor via combination umbilical pressuretube 43 which carries individual pressure tubes, one of which ispressure tube 45. These pressure tubes are pneumatically coupled to atest port panel 47. Remote control device 41 is electrically connectedvia electrical cable 49 to the test port panel 47 through an aperture inthe panel.

Examination unit 10 includes a number of pull-out drawers or piano hingefront panels 51, 53, 55, and 57 as well as a pull-out drawer 59. In eachone of these drawers, the technician can store various pressure cuffs,cables, and other connective devices or medical supplies which may beused during the vascular examination of patient 23. Additionally,disposed in the interior of one or more of these drawers is the pulsevolume recorder PVR, the ophthoplethysmograph, equipment for theaudio-frequency analysis AA unit and particularly the sensitivemicrophone used in connection with that unit, and the continuous wavedoppler ultrasound unit as well as the doppler probe. Test port panel 47(discussed later in connection with FIG. 3), provides both a pneumaticand electrical connection port to the pressure cuffs, pressure cufftubes (43, 45) and electrical ports for the connection to the electricalsensing devices such as the sensitive microphone for the AA unit and theultrasound probe for the doppler ultrasound unit.

As is common in vascular tests, the technician may wear a pair ofmicrophones 61 which are placed on table top 63 of analyzing unit 12.Particularly, when using the doppler ultrasound, the technician willwear headphone 61 about his ears and blood flow in one direction isidentified by an audio sound in one ear as compared with blood flow inthe opposite direction which is identified by an audio sound in theother ear. Headphones 61 are cordless headphones and as such theyreceive a radio frequency RF signal transmitted by the computer systemin the examination unit. Remote control device 41 enables the technicianto walk around and move about patient 23 while patient rests on tabletop 21 of examination unit 10. Further, flying monitor 17 enables thetechnician to move and adjust the monitor for the best view during thevascular examination.

Examination unit 10 also includes a foot control 71.

Additionally, examination unit 10 may include an external speaker if thetechnician wants to audibly hear the ultrasound signals or the audiofrequency signals.

Analyzing unit 12 includes a computer system 16, a monitor 73, akeyboard 75, a mouse or track ball 77, and a printer 79 which ispreferably a color printer. All of these electrical equipment areconnected together as is common in the industry. In addition, there is acomputer system in examination unit 10 which is not immediatelyidentified in FIG. 1. The computer system in examination unit 10 iselectrically connected via cabling 14 and a local area network(Ethernet) to computer system 16.

During the report generation phase, the technician can wear headphone 61and view the vascular reports on display monitor 73. By inputting theproper command controls via mouse 77 or keyboard 75, the user can listento the analog version of the stored digital instrument data signals. Inthis manner, the technician can associate in the electronic format theaudio doppler signals and the audio-frequency analysis AA signals whilehe or she prepares the vascular diagnostic report for the particularpatient. Since the digital instrument data signals are electronicallylinked in the database to the keypad entry data signals, a completevascular diagnostic report can be visually presented on monitor 73 tothe technician and also audibly presented to the technician. Since thisdata is electronically connected together, the data as well as thereport can be sent over a wide area network or over the Internet toother computer systems for further analysis and review by otherphysicians.

As used herein, the term "digital instrument data signals" refers to thedigital version of any instrument data signals output by the vascularmedical equipment, e.g., the PVR, OPG, doppler or OPP.

One of the important features of the present invention is the integratednature of the entire vascular diagnostic system. This system prompts thetechnician to conduct the vascular exams in a certain manner, requestkeypad entry data from the technician, prompts the technician to gathercertain instrument data signals such as signals from the PVR, OPG, PPGand AA as well as the ultrasound doppler signals, places all this datain a database, and then enables the technician to generate a vasculardiagnostic report.

The AU or analyzing unit provides a means to gather and store allnecessary data about a patient in order to characterize his vascularhealth. Certain data will be provided by external input. The systemoperator or technician will either input data using a keyboard (keyboardentry data) or reload data from an auxiliary storage tape. Currentvascular data will be generated and stored based on running a series ofdiagnostic exams on the patient by the operator at the EU or examinationunit.

The AU also provides a means to input and store all appropriate census,vascular history, vascular studies required, and other patient data froman external source. New information will be entered via keyboard.Previously gathered information stored on an auxiliary storage tape willbe reinstalled on the system. This enables the technician to comparecurrent vascular exam data with previously obtained data. Any patientdata currently in the system will be augmented or updated via thekeyboard.

The AU will take the vascular study requirements data and translate itinto the specific diagnostic tests needed to be performed at the EU.

The EU enables the technician to gather patient vascular data. Itprovides a means to gather and store all necessary vascular data byrunning a series of diagnostic tests on the patient. The diagnostictests to be run are as defined by the AU and the selected tests areeither downloaded to the computer system in the EU or commandsrepresenting the selected tests are sent via the Ethernet LAN to the EUcomputer system. Diagnostic tests are run using the followinginstruments in the EU examining table:

Pulse Volume Recorder (PVR)--The function of the PVR is to obtain aseries of waveforms from a set of cuffs on either the lower or upperextremities which correlates to the amount of blood flowing beneath itwith each heartbeat. Also segmental systolic pressures can be measuredusing the occlusion technique.

Bi-directional Continuous-Wave Doppler--The function of the ultrasounddoppler is to detect movement and the direction of blood flow in botharteries and veins. The probe sends and receives ultrasound waves. Thechanges in frequency of the emitted and received signals are processedelectronically and presented as either a sound in the headphones 16and/or as a waveform on the display 17.

Audiofrequency Analyzer (AA)--The function of the AA is to listen andcharacterize blood flow via audio means using a sensitive microphone.The received signals are processed electronically and presented aseither a sound in the headphones 16 and/or as a waveform on the display17.

Ocular Pneumoplethysmograph (OPG)--The function of the OPG is to measureophthalmic artery pressure in both eyes. Small suction cups are placedon the sclera of the eyes. These eyecups record minute volume changesduring a continuously declining vacuum. This vascular exam has beencorrelated with the intraocular pressure. The intraocular pressure atthe time of the first ocular pulsation is stored as the ophthalmicsystolic pressure. The received instrument data signals are processedelectronically and presented as a waveform on the display 17.

Photoplethysmograph (PPG)--The function of the PPG is to monitor bloodflow for systolic pressure measurement, venous reflux testing, andarterial blood flow. The PPG probe emits a measured amount of light froma light emitting diode (LED) into the tissue and measures the amount oflight returned to the probe. The difference between the two measurementsis actually the quantity of blood in the tissue. The blood actuallyabsorbs some of the light from the LED. The received signals areprocessed electronically and presented as a waveform on the display 17.

Computer Hardware Subsystem

EU or examination unit gathers and stores all necessary vascular databased on running a series of diagnostic tests or exams on the patient bythe operator. The EU consists of the examining table, diagnosticmodules, a computer subsystem, and a step stool.

The examining table houses the diagnostic modules and the computersubsystem. It provides a place for the operator to gather data from areclining patient using the diagnostic modules. In one embodiment, theexamining table is made of wood with all exterior surfaces covered informica. The total table height (to top of the comfort pad) is 32inches. It is topped with a two-inch thick comfort pad. Fixtures locatedon the side of the table at its head allow the OPG eye cup transducersupport arm assembly, along with the monitor arm assembly 19, to beconveniently mounted. This 14-inch diagonal flat screen monitor ismounted on a swing-arm and support post above the table surface. The OPGtransducer arm 27 swivels in its mount. There are two pull out arm restshelves located just below the top's formica surface. The OPG footswitch71 extends from its cord at the table's base.

FIG. 3 diagrammatically illustrates a test port panel. The table has atest port panel 47 that has quick disconnect tube fittings, one of whichis fitting 102, for the cuffs. See FIG. 3. An additional quickdisconnect is provided for a hand pump bulb/valve assembly 104 andpenile cuff fitting 106. There are four electrical jacks for the dopplerelectrical data and control port 108, PPG electrical port 110,microphone port 112, and patient music headset port 114. Each connectionport and control port has its own identifying label plate. The test portpanel is tilted out to 45 degrees during use so that it can readily beseen by the operator to make connections and manipulate controls.

There are 11 air tubing quick disconnect ports for cuffs. This includesthe following:

Pneumatic Quick Disconnect Ports

Right Leg/Upper Arm Cuff

Left Leg/Upper Arm Cuff

Right Calf/Lower Arm Cuff

Left Calf/Lower Arm Cuff

Right Ankle Cuff

Left Ankle Cuff

Right TM Cuff

Left TM Cuff

Right Toe Cuff

Left Toe Cuff

Penile Cuff

There are at least three electrical jacks in the test port panel. Thefourth jack 114 for a music headphone connection for patient listeningnecessitates the addition of a small portable audio CD player in theexamination table. The electric jacks are listed below:

Electrical Port Table

Doppler Probe

PPG

Audiofrequency Analyzer Microphone

Patient Music Headphone (option)

FIG. 2 diagrammatically shows combination or umbilical cord 116 forpneumatically linking ankle, calf and thigh cuffs 118, 120, 122 to thepneumatic system in the examination unit EU 10. These cuffs have quickdisconnect couplers, one of which is coupler set 124 which connects toumbilical cord set 116. The opposite end has quick disconnect fittings118 which pneumatically connect with the ports on test port panel 47.See pneumatic port 102. The umbilical cord set permits theoperator/technician to better organize multiple pressure tubes during aPVR exam.

The test port panel diagrammatically illustrated in FIG. 3 holds aRemote Control Device (RCD) (diagrammatically illustrated in FIG. 5)that is used in place by the operator or is removed for use on ahand-held basis. The RCD is held in place on the panel with magneticcatches. The RCD is used by the operator to control the diagnostictests. During patient audiofrequency amplifier (AA) testing the operatoruses wireless headphones 61 during the course of the tests. An AAmicrophone is plugged into the test port panel at electrical port 112.

The configuration of the examination table consists of a top section anda recessed base section. The top section has a table top surface, pad,slide-out arm rests, test port panel, computer storage area and threedrawers. There will be sufficient storage for most of the diagnosticinstruments, CPU assembly, cuffs, and probes. There will also be somestorage space for medical supplies such as linen sheets, towels andlatex gloves. The test port panel is located on the middle of the sidepanel between two sets of two drawers. The left most drawer near themonitor swingarm 19 is a false drawer. It has a bottom hinged front witha touch latch at the top to allow access to the CPU assembly housedbehind it. The other drawers are accessed by recessed grip surfacesrunning along the bottom of the drawers. The recessed base section has apedestal. The pedestal houses the OPG and the UPS. The OPG is located ina pull-out drawer on the side of the pedestal.

FIG. 4 diagrammatically illustrates the pneumatic schematic for thepresent invention.

As discussed earlier, one or more pressure cuffs are placed on theextremities of patient 23 during a certain vascular exams. These cuffsare commonly used in connection with a pulse volume recorder.

The internally calibrated pulse volume recorder 130 or ICPVR is a boardinstalled in an expansion slot of the computer system located in theexamination table. Flexible tubing running from the ICPVR connects totwo- and three-way solenoid valves that route air pressure to thecorrect test port panel quick disconnect fittings.

The blood pressure cuffs for use with the current embodiment of theperipheral vascular lab or PVL are discussed below. They are sized to beused with specific locations on an adult. All cuffs are of the singletube style. The cuffs are connected to tubing that ends with a quickdisconnect fitting that plugs into an appropriate port on the test portpanel.

Thigh--Single tube Bladder and Cuff Assembly, Baum "Thigh" Cuff

Calf/JUpper Arm--Single tube Bladder and Cuff Assembly, Baum "Large Arm"Cuff

Lower Arm--Single tube Bladder and Cuff Assembly, Baum "Adult" Cuff

Ankle--Single tube Bladder and Cuff Assembly, Baum "Large Arm" Cuff(same cuff as for Calf)

Transmetatarsal (TM)--Single tube Bladder and Cuff Assembly, Baum"Child/Small Adult" Cuff

1st Digit--Single tube Bladder and Cuff Assembly, Hokanson

Penile--Single tube Bladder and Cuff Assembly, Hokanson.

The umbilical cable assembly of FIG. 2 is made up of three tubescombined into one unit. It simplifies the leg cuff hookup process. Theumbilical's tube ends have quick disconnect fittings to allow the thigh,calf and ankle cuffs to be easily connected to the test port panel.

The bladder pressurization bulb/flow control valve assembly is used toallow cuffs to be manually pressurized and deflated. This bulb assemblymade by Baum will be connected to tubing that connects to thepressurization valve via a test port panel connection.

FIG. 4 shows a plurality of controllable solenoid valves. Theseminiature solenoid valves are used to electronically select the specificblood pressure cuffs to be pressurized by the ICPVR. The two-way valves(V-12, V-13) are used to select between the two legs/arms cuff positionswhile the three-way valve (e.g., V-1) is used to select a specific cuff.Additional two-way valves (V-17, V-14, V-16, V-15, V-18) are installedto support a specific test that requires the thigh cuff to be isolatedand pressurized/deflated using the hand bulb while the calf cuff isbeing pressurized simultaneously by the ICPVR card. All of these valvesare located within the examination table behind the test port panel.Relief valve V-19 is also provided.

FIG. 5 diagrammatically illustrates remote control device RCD 140. Thisremote control device is utilized by the operator/technician to controlthe operation of ICPVR 130 and the other non-invasive medical units inthis integrated system. Additionally, RCD 140 can be utilized to inputkeypad entry data based upon manually acquired vascular medical datafrom the patient.

In one embodiment, RCD 140 includes a 40 character display 142 whichenables the operator to scroll through the instructions based upon theactuation of left or right arrows 144 and 145. The control device alsoincludes a shift key 146, numerical keys 148, a period key and a pluskey. The following remote control keypad table lists some of the keysthat are available on RCD 140.

    ______________________________________                                        Remote Control Keypad Table                                                   ______________________________________                                        Left arrow     Function Key 1 - Next                                          Right arrow    F2 - End of test                                               0-9 digits     F3                                                             Period (.)     F4                                                             Plus (+)       F5                                                             Shift          F6 - gain                                                                     Level 1, Lev - 2, Lev -                                                       3, Lev- 1                                                      Enter                                                                         ______________________________________                                    

In general, the operator is prompted to conduct certain vascular examson the patient based upon the flying monitor screen 17. Additionally,the operator can be prompted to input keypad entry data or to acquiredigital instrument data based up the information on display 142 of RCD140.

As an example, to change the exam, the operator would select functionkey 1 which is the next key. This command entry provides an indicationto the computer system and the examination unit (FIG. 6) that thecomputer system must provide the operator with additional informationfor the next sequential vascular exam. At the end of the vascular exam,the operator presses the F2 "end of test" key.

RCD 140 has six programmable function keys, F1-F6. Function key F6 maybe set to adjust the gain of the instrument data signal. Certainvascular tests or exams may require that the operator/technician adjustthe gain on the signal displayed on flying monitor 17. As an example,programmable function key F6 can be programmed to adjust the gain tothree distinct levels. To go from level 1 to level 2, the operator couldpress right arrow 145. Another depression of right arrow 145 shifts thegain from level 2 to level 3. A further depression of the arrow keyreturns the gain back to level 1. Of course, the gain could be adjustedby programming function F6 (or any other function key) to have multiplelevels of gain.

Also, an analog gain control could be added to test port panel 47.

The enter key on RCD 140 is utilized by the operator to command a"record digital instrument data signal" to end such recording or toenter keypad entry data into the RCD.

FIG. 6 diagrammatically illustrates the electrical hardware diagram forthe examination EU unit as well as the analyzing AU unit.

The computer subsystem in the AU is composed of a Pentium 133 Mhz CPUwith 32 MB of RAM running Windows 95, a 1.6 GB hard drive, a 3.5-inchfloppy drive, a 17-inch noninterlaced super VGA monitor, a two-buttonmouse, a Windows 95 keyboard, a video card with two MB VRAM, and anEthernet interface card. Additional peripherals include a 2.0 GBinternal tape backup, a 4× speed CD-ROM, a 28.8 facsimile/modem, a 600DPI color inkjet printer, a one-KVA uninterruptable power supply (UPS),and an eight-port 10 Base T Hub for a communications interface with theEU.

The examination unit or EU 212 includes a similar type of computersystem as compared with AU 210.

The Examination Unit (EU) computer subsystem provides an operatorinterface for control and data collection for the various vasculardiagnostic instruments. The computer is a Pentium 133 MHz single boardcomputer (SBC) with 16 MB of RAM running Windows 95, a 1.2 GB harddrive, a 3.5-inch floppy drive, a 4× speed CD-ROM, and an Ethernetinterface card all contained within a slide out chassis and an AT backplane.

Display for the system will be an active matrix, thin film technology(TFT), liquid crystal display (LCD), 640×480 color VGA flat panelmounted on a swing arm above the patient and in clear view of theoperator. The screen size (diagonal) is 14.2 inches with a display pitchof 0.46 mm×0.45 mm. The display weight is approximately 5.5 pounds. Thedisplay will contain a backlight and use six bits per color. The displaywill be powered by 5 VDC and 12 VDC from the PC chassis.

Operator control is exercised through a micro terminal remote controldevice (RCD), connected to the computers RS-232 interface. The unitcontains a 1 by 16 by 0.25 inches high alphanumeric display with a 80character buffer, six user-programmable keys, numeric keypad, anddirectional keys. The RS-232 baud rate to and from the RCD is 9600 Baud.The RCD connects to the test port panel via a cable that is long enoughto allow it to be removed and used in a hand held mode.

Installed in the EU computer chassis is the ICPVR card and the analog todigital converter (ADC)/discrete input/output card. Both cards plug intothe AT back plane. The ADC card digitizes analog data to 12 bits at a100 KHz rate and stores it on the computer's hard drive for analysis andreport generation. Sixteen (16) single ended inputs are internallymultiplexed and are available to the ADC with a full scale input of+/-10 V and selectable gains from 0.5 to 100. The ADC card performs thefunction of a strip chart recorder: recording tests results for lateranalysis. Vascular diagnostic instruments are connected to the ADC forthe recording of test results.

The discrete inputs and outputs of the ADC card are used to control thepneumatic switching for the ICPVR, PPG and Doppler operation. The footswitch for the OPG is sensed by discrete inputs to start datacollection. A total of eight TTL compatible signals configurable asinputs or outputs are available for use. In order to drive the pneumaticselector valving for the ICPVR, a driver circuit is used to operate thevalve's solenoids.

Examination unit 212 includes an internally calibrated pulse volumerecorder ICPVR 130 which is described in detail in connection with FIGS.8A, 8B and 8C. That ICPVR board is mounted in the computer system for EU212. The board includes both pneumatic and electrical devices. Thepneumatic output from ICPVR 130 is applied to a pneumatic switch system214. FIG. 4 diagrammatically illustrates the pneumatic schematic ofpneumatic switch system 214. The pneumatic output of pneumatic switchsystem 214 is fed to vascular cuffs 216. These cuffs are discussedabove.

Also connected to the computer system of EU 212 is a 12 bitanalog/digital and discrete input/output board 218. That board iselectrically connected to an interconnection circuit 220. Furtherdetails regarding the interconnection circuit 220 is discussed later inconnection with FIG. 7. Analog and control information is applied frominterconnection circuit 220 to the OPG 222. Accordingly, control signalsare applied to OPG 222 from interconnection circuit 220 and analoginstrument data signals are generated by OPG 222 and supplied tointerconnection circuit 220. Interconnection circuit 220 then suppliesthese received analog instrument data signals to the A/D input/outputdevice 218 and device 218 converts them to digital instrument datasignals. These digital instrument data signals are then processed asdiscussed later by processor 224 in the EU computer system 212.

Interconnection circuit 220 is electrically connected to PPG 226. PPG226 is connected to the PPG probe 228.

Interconnection circuit 220 is also connected to microphone 230 andanalog signals pass between microphone 230 and interconnection circuit220.

Interconnection circuit 220 is also electrically connected to a mixer232. Mixer 232 includes a radio frequency RF transmitter which sends RFsignals to headphones 61. Headphones 61 include an RF receiver such thatthe operator can walk around the patient and listen to analog versionsof the instrument data signals.

Interconnection circuit 220 is also connected to the bidirectionalcontinuous wave doppler 234. Doppler unit 234 is electrically connectedto doppler probe 236.

Interconnection circuit 220 is also connected to foot switch control238. As discussed herein, foot control 238 is used in connection withOPG 222.

FIG. 7 diagrammatically illustrates in greater detail the peripheralvascular lab PVL input/output board 221. This PVL I/O board 221 issubstantially similar to the interconnection circuit 220 and thecomputer system for EU 212. The electrical interconnection between theremote control device 140, the processing unit 224 for the computersystem 212 and the flying LCD display 17 (FIG. 1) is illustrated in FIG.7. Additionally, FIG. 7 shows that audio mixer 232 is connected toheadphone transmitter 233.

FIGS. 8A, 8B and 8C diagrammatically illustrate three differentembodiments of the internally calibrated PVR. A further explanation ofthe internally calibrated PVR is found in U.S. patent application Ser.No. 08/484,933, filed Jun. 7, 1995 and U.S. patent application Ser. No.08/608,825, filed Feb. 29, 1996. The contents of those two pendingpatent applications are incorporated herein by reference thereto.

FIG. 8A diagrammatically illustrates the hardware for one embodiment ofthe internal calibration for the PVR. In general, the calibration deviceis part of computer system 224. In FIG. 8A two pressure cuffs 32 and 34are illustrated. Pressure cuff 32 is generally a cylindrical pressurecuff that is commonly used on an arm or a calf. In contrast, cuff 34 isa conical cuff such that proximal end 36 has a smaller diameter ascompared with distal end 38 when the conical cuff is placed about thethigh of a patient. These cuffs are similar to those described earlierherein.

Each cuff has a coupling hose 33 and 35 and a pneumatic attachablecoupler 37, 39 which attaches to a port 40. Port 40 is equivalent to thepneumatic ports on test port panel 47. The intervening valve assembly214 is not shown in FIGS. 8A, 8A and 8C. Port 40 leads to a pneumaticsystem generally illustrated by tubes, couplers, hoses or pipes 42 whichare inside the container of computer system 224.

Pneumatic internal coupling system 42 is connected to a pump 44, a valveV₁, a safety valve 46 (SV) and a pressure sensor 48 (S). Additionally,valve V₁ is pneumatically connected to a second valve V₂ via a closedchamber 50 having a pre-determined volume. The pre-determined volume inchamber 50 is about 1 ml. or 1 cc. Chamber 50 is a tube having an insidediameter of 4.5 mm and approximately 63 mm (2.48 inches) long. Bymaintaining valve V₁ closed while the cuff pressure in elevated to apredetermined level, (for example 70 mmHg), and then opening valve V₁while maintaining valve V₂ closed, the volume in the closed pneumaticsystem (defined by substantially by the pressure cuff), is changed by apre-determined volumetric amount. The electric signals, preciselyrepresenting pressure generated by pressure sensor 48 during thepneumatic calibration routine, provides a calibration signal which isused to calibrate the PVR or blood flow or volume monitoring system.

FIG. 8A also diagrammatically illustrates the general electricalcomponents and electrical system connections for the computer system.For example, valves V₁, V₂, pump 44 are all supplied with power (thepower lines are not shown) and control signals. The control signals aregenerally sent from signal conditioner 54 to the valves and the pump.Signal conditioner 54 is coupled to an internal bus 56. This internalbus (on the pressure sensor board) also carries data and control signalsto and from and analog/digital (A/D) device 58. A/D 58 is electricallyconnected to pressure sensor S 48 as shown in FIG. 8A. Internal bus 56is also connected to a micro controller 60 as well as a memory 62.Memory 62 may be a programmable read only memory (PROM) or otherelectronic device that stores computer programs. The code or micro codestored in memory 62 is utilized by micro controller 60 to drive, inconjunction with signal conditioner 54, valves V₁, V₂ and pump 44. Microcontroller 60 also obtains, reviews and sends signals to and from A/Dconverter 58.

The output from A/D converter 58 is, as is known in the art, placed in abuffer and made available to other computer components via the maincomputer bus 70. This main computer bus is accessible to the centralprocessor in computer system 224.

Upon opening valve V1, the closed pneumatic system primarily containedby pressure cuff 32, 34 experiences a change in volume by apredetermined amount. This predetermined amount is the interior size ofthe chamber defined by tube or cylinder 50. In one embodiment, thischamber and predetermined amount is 1 ml. The 1 ml volume change resultsin a change in the pressure signal, thereby causing the calibrationpulse at a predetermined time. The calibration pulse is delivered ateach discrete cuff pressure level. Accordingly, at cuff pressure levels50, 60, 70, 80 . . . 160 during a peripheral vascular exam using thePVR, the system will generate a calibration pulse and change the volumein the closed pneumatic system by a predetermined amount of 1 ml.

FIG. 8B diagrammatically illustrates a pneumatic calibration system andthe method for calibrating either a volume plethysmograph or a pulsevolume recorder. It is the currently preferred embodiment of the ICPVR.The pneumatic calibration system illustrated in FIG. 8B includes abiased piston 510 that is utilized to change the volume by apredetermined amount in the closed pneumatic cuff system which includescuff 512. The closed pneumatic system includes cuff 512, generallyflexible hose 514, coupler port 516, and generally rigid tube sections518, 520, 522, 524 and 526. The valve assembly 214 and test port panel47 is omitted in FIG. 8B. Cuff valve V₃ is interposed between tubesections 516 and 518. On the outboard side, cuff 512 is pneumaticallycoupled to cuff valve V₃. On its inboard side, cuff valve V₃ ispneumatically coupled to tube sections 518, 520, 522 as well as pump 530and pressure sensor S532. Pump 530 is driven by a drive signal Dr.Pressure sensor S532 generates a pressure sensor signal Sd. Exhaustvalve V₄ is pneumatically coupled to tube sections 522 and 524. Exhaustvalve V₄ is a two way valve wherein the exhaust port 532 of valve V₄ isnormally closed but an interior passage links tube sections 522 and 524together until the valve opens. When exhaust valve V₄ opens, air flowpasses from the interior of tube section 524 and out of exhaust port532. In other words, tube sections 518, 520, 522 and 524 are normallymaintained at substantially the same high pressure level, that is, abovethe ambient pressure level. This high pressure level is equivalent tothe discrete cuff pressure levels. This high pressure in the system isdue to the injection of air into the closed pneumatic system by pump530.

During normal operation when cuff 512 is pumped up to a discretepressure level, exhaust valve V₄ is in a closed position (closed toexhaust port 532) and the air pressure in tube sections 518, 520, 522and 524 affect the backside or rearface 540 of piston 542. Piston 542moves within an interior space 544 of piston system 510 based upon apressure differential between its rear and front faces. The piston is ata top position closest to terminal end 546 when cuff valve V₃ is openand valve V₄ has its exhaust port closed. Since valve V₄ is a two wayvalve, when that valve's exhaust port is closed, there is a fluid orpneumatic communication between tube segments 520, 522 and 524. Piston542 is biased by a spring 560. Also during normal operation, that is,when cuff 512 is being pumped to or maintained at a discrete pressurelevel (for example 60 mmHg), the pressure in the system is substantiallyidentical in tube segments 516, 518, 520, 522, 524, 526 and in pistonchamber 544.

When the electronic components of the ICPVR issue a calibration triggersignal, cuff valve V₃ closes, exhaust valve V₄ opens to exhaust andpiston 542 moves towards its bottom position thereby compressing spring560 and adding approximately 1 ml of calibrated volume to the closedpneumatic system. In a preferred embodiment, 0.6 ml volume is added tothe closed pneumatic system which includes cuff 512. The calibrationtrigger signal is, in reality, several electronic signals includingcontrol signal cV₃ applied to cuff valve V₃ and signal cV₄ applied toexhaust valve V₄. The signals are applied with the appropriate timedelay in order to effectively isolate the cuff 512 prior to venting thebackside of piston 542 and also to reduce jolts or undue transientchanges in the closed pneumatic cuff system. When exhaust valve V₄opens, piston 542 moves to a bottom position or away from terminal end546 thereby adding a predetermined calibration volume to the closedpneumatic system. A flow restrictor R550 acts as a pneumatic damper forthis change in volume.

Throughout this cycle, sensor S532 is substantially, continuallygenerating pressure sensor signals Sd. These pressure sensor signals areapplied to A/D converter 58 (FIG. 8A) and representative signals areapplied to microcontroller 60 as well as processor 224. The OperationTable which follows summarizes the calibration method.

    ______________________________________                                        Operation Table                                                                            Valve 3    Valve 4                                               Condition    (to cuff)  (to exhaust)                                                                            Piston                                      ______________________________________                                        pump-up cuff open       closed    top                                         at discrete P levels                                                                       open       closed    top                                         at cal. trigger                                                                            closed     open      bottom                                      post trigger time                                                                          open       closed    top                                         ______________________________________                                    

In the current preferred embodiment, in order to move piston 542 to atop position, pump 530 is driven for a short period of time (byapplication of drive signal Dr) which causes an increase in pressure inthe pneumatic calibration system after cuff valve V₃ is opened and theexhaust port on valve V₄ is closed. Since pressure sensor S532continually monitors the pressure in the closed pneumatic cuff system(including cuff 512), the motor and pump 530 combination cycles on andoff to maintain the pressure at the predetermined discrete pressurelevel (for example 80 mmHg) throughout that portion of the medical test.Tests have shown that there is no significant change in the pressure inthe closed pneumatic system which includes cuff 512 when pump 530 isturned on for a short period of time to move piston 542 to its topposition towards terminal end 546.

FIG. 8C diagrammatically illustrates another embodiment using a positivedisplacement pump (PDP) 410 driven by a stepper motor 412. This pump mayinclude a piston which, at each cycle, injects a known volume of airinto the pneumatic system. The internal pneumatic coupling system 414includes a mechanical coupler 416 which can be attached pressure cuffs32, 34, and particularly coupler lines 39 and 37 shown in FIG. 2.Pressure sensor 420 is also pneumatically connected to the internalpneumatic line 414. A/D converter 424 obtains and converts the signalfrom pressure sensor S 420. Signal conditioner 426 generates signals tocontrol the stepper motor which in turn controls the positivedisplacement pump. Microcontroller 430 and memory PROM 432 control theA/D converter 424 as well as the stepper motor 412.

In operation, the positive displacement pump injects a certain amount offluid or air into the cuff pressure based upon the number of turnsstepper motor 412 delivers to the pump drive. Accordingly, a steppermotor driven to a certain level (a certain number of rotations) candrive a positive displacement pump to a certain level and inject apredetermined amount of volume of air into the closed pneumatic systemat each cuff pressure level. This injection of a calibration volume ofair into the system is used to calibrate the pneumatic gain at eachdiscrete cuff pressure level as explained earlier. Instead of evacuating1 ml of air, the stepper motor and PDP pump injects 1 ml of air into thesystem.

In addition to the ICPVR, the integrated peripheral vascular lab usesthe following equipment.

Bi-directional Continuous-Wave Doppler

The selected bi-directional, continuous wave, doppler ultrasound systemis a Hokanson Model MD6. It operates at a 5 MHz single frequency. Thisdoppler weighs 9 ounces and is small enough to fit into a coat pocket. Ahigh quality audio signal is provided by stereo earphones or a built-inspeaker by the use of dynamic noise reduction circuitry. Direction ofblood flow is perceived by the operator with stereo earphones; flowtoward the probe is heard in the left ear and flow away is heard in theright. In addition to the audio signal, the operator can visuallydetermine the direction of flow by red and green LEDs on the probe'send. An on/off switch is also located on the probe. The dopplerultrasound system uses rechargeable batteries with an automatic shutdownto prevent accidental battery drain. The doppler ultrasound has ananalog output connection that normally allows it to be hooked to aseparate chart recorder. In this integrated system, the chart recorderoutput is connected to the analog-digital converter board 221, via aplugjack to the test port panel 47 and the interconnection circuit 220.

Audiofrequency Analyzer (AA)

A microphone and a wireless radio frequency (RF) headphone set 61supports the AA functions. There is a plug jack 112 at the test portpanel 47 for the microphone electrical cord which will include theanalog signal and ground. The analog signal is routed to the pre-amp onthe interconnection circuit 220 which provides a 20 dB gain to theanalog signal. The amplified analog signal is sent to the analog/digitalconverter board 218 where the signal is digitized and the resultsdisplayed graphically on the flat panel display 17. Also, the amplifiedsignal is sent to the audio mixer 232 and from there is sent to thewireless RF 900 MHz headset transmitter 233. If the doppler ultrasoundis being used by the operator, then the output of the pre-amp to theaudio mixer for the microphone is grounded using the discreteinput/output (I/O) capability of the analog/digital converter board,thereby disabling the audio output of the microphone.

Ocular Pneumoplethysmograph (OPG)

The OPG is an Electro-Diagnostic Instruments (EDI) model OPG-5D. Itmeasures pressure in the ophthalmic artery. This functional measurementmay be a predictor of significant extracranial carotid artery diseaseand its prognosis. The transducer 25 and its associated arm 27 ismounted on the end of the examination table 10 adjacent to the monitorswing arm 19. The footswitch 71 is wired to a connector in the base ofthe table.

Photoplethysmograph (PPG)

The PPG is a Hokanson Model MD6RP. The unit allows both AC and DC modetesting for all common PPG tests. The PPG includes an output that isnormally used for sending data to a chart recorder and also as its powersource. In this integrated system, the chart recorder output isconnected to the analog-digital converter board 218, via a plug jack tothe test port panel 47 and the interconnection circuit 220.

FIGS. 9, 11, 12 and 13 generally show basic flow charts for the basic AUprogram, the basic EU program, the generate report program and thereview report program. FIG. 10 generally illustrates the user interfaceintroduction into the review report or the generate report program.

AU Computer Software

The AU operating system is Microsoft Windows 95.

Applications software used with the AU computer is Microsoft OfficeProfessional 95. It includes Microsoft Word word processing software,Microsoft Excel spreadsheet software, Microsoft Access relationaldatabase software, Microsoft PowerPoint presentation graphics softwareand Microsoft Schedule personal/group scheduling software.

AU Main Program

The AU main program software is based on Microsoft (MS) Access, acommercial off the shelf database management system. Data entry screens,report generation, and database update software will be written inAccess Basic which interfaces directly with MS Access. Other softwaremay be written in Borland C. The user interface is a standard Windowsinterface with user selections made with a point and click of a mouse.

The AU software generally shown in FIGS. 9 and 10 consists of six majorcomponents: (1) user interface, (2) built-in test (BIT), (3) patientdata entry, (4) report generation, (5) report review, and (6) systemmanagement.

AU User Interface

The user interface is normally controlled with a keyboard and mouse. Onsystem powerup, an operator log-in screen is displayed. The operatorthen enters his unique identification code and password. If successful,then a Main Menu screen (see FIG. 9) is displayed which will give theuser the option to (1) initiate BIT 310, (2) enter patient data 312, (3)generate report 314, (4) report 316, and (5) system management 318. Theoperator makes his selection with a point and click of the mouse. Thisresults in a new set of menu options displayed. The user has the abilityto return to the main menu from within any submenu.

Only those menu options available to a particular operator are displayedfor any given menu. The options available are determined by his accesslevel which is based on his unique identification code which is enteredinto the system through the System Management option of the AU software.

Built-In Test (BIT) Module

The AU initiates a BIT routine 310 to be executed on the instrumentcontrol system. The results are made available at the AU and aregrenerally viewable on monitor 73 (FIG. 1). On powerup, BIT will beautomatically executed. If a discrepancy is discovered, then a warningmessage describing the discrepancy will be displayed on the AU monitor.The operator has the option of initiating BIT at any other time afterpowerup. The results of each BIT is displayed on the console screenstored on the hard drive at the AU.

Step 320 checks the AU and the EU computer systems. Step 322 checks themedical equipment shown in the following table.

Check Medical Equipment Table

Pump on ICPVR board

Test all A/D converters

Sample continuous wave doppler board

Test OPG board

Test remote control device

In step 324, the error code is displayed, if necessary.

Patient Data Entry

The operator has the ability to enroll new patients into the AU databaseand can update/add data on patients currently enrolled into the AU. Newpatients are enrolled into the AU via a Patient Census Information InputScreen which includes name, age, sex and other general information. Seestep 326, FIG. 9.

Once the patient is enrolled into the database, the operator can thenenter patient history, patient physical information, such as a bloodpressure measurement or serum sample results, and other manual vascularexam results, performed by the technician at the EU. This data may beentered in via the keyboard and mouse or may be entered via computerreadable media.

Report Generation

The operator has the ability to generate the following study reports(step 316, FIG. 9): (1) Complete Lower Extremity Venous Study Report,(2) Complete Lower Extremity Arterial Study Report, (3) Complete ExtraCranial Arterial Study Report, (4) Complete Upper Extremity Venous StudyReport, and (5) Complete Upper Extremity Arterial Study Report. Thestudy reports will be generated based on the data collected during thetests or vascular exams run on the EU.

Most of the information placed in the report is automatically importedfrom the EU, but some data requires user selections to be made. Thetechnician, at the EU, collects several seconds of data which willinclude several heart cycles for the doppler ultrasound and audioanalyzer, for example. The AU operator is able to display and listen toall of the recorded heart cycle data and then will select three cyclesthat best represent the vascular condition of the patient. Thecorresponding graphical representation of the selected heart cycles willbe included in the study report.

Report Review

The operator has the ability to review any study report previouslygenerated for a particular patient. When Report Review is selected, alist of patients with generated reports is displayed. Then, the operatorselects a patient and a list of study reports for the particular patientwill be displayed. Next, the operator selects a study report and thenthe study report is displayed. The operator may scroll through thereport in any direction. Integrated with each report will be thecorresponding sound data (analog versions of recorded digital instrumentdata) for items such as the doppler ultrasound and audio analyzer AA.The operator is able to click on a given sound and can hear what thetechnician heard at the EU. The operator can print the study report onthe color printer at the AU.

System Management

When the operator selects System Management, two options are displayed:(1) User Passwords and (2) Data Archive. The User Password optionpermits the operator the ability to add/delete/modify useridentifications, passwords and access levels. See step 330, FIG. 9.

Data Archive gives the operator the option of archiving patient dataonto a back-up tape storage device, deleting patient data, and recallingpatient data from a back-up tape. See step 331, FIG. 9.

FIGS. 12 and 13 generally provide flow charts for the generate reportprogram (FIG. 12) and the review report program (FIG. 13).

In FIG. 10, screen display 450 prompts the technician to input patientdata. The next screen display 452 graphically shows various vascularexaminations (Exam 1-6), a front view 454 of a patient model and ananterior or back view 456 of a patient model. Additionally, the patientname is presented to the technician in area 458, the referring doctor ispresented in area 460, the technician's name is presented in area 462and the date is presented in area 464.

Returning to FIG. 12, the generate report program, in step 468, thetechnician is presented with a list of patients. He or she selects apatient from the list. This is noted in step 469. The technician is thenpresented with a display screen generally similar to that shown asdisplay screen 452 in FIG. 10. The technician is presented with aselected exam results, in this case, vascular exam results 1 in step470. The technician can scroll through exam subpart 1, subpart 2, aswell as exam 2, and exam 3 in step 472. In step 474, the technicianreviews the acquired data. This data is acquired at the examination unitas described later herein. In step 476, the technician selects a portionof the digital instrument data signal. For example, for the continuouswave doppler ultrasound exam, the technician will initially select aboutten seconds of the ultrasound doppler at the examination unit. Duringthe generate report program, the technical will select a three-secondsegment of that originally obtained ten second digital data signal.

In step 478, the technician can play back or listen to the ultrasounddoppler signal. This is an analog version of the digital instrument datasignals for the ultrasound doppler. In step 480, the technician canannotate the report. In step 482, the technician stores and/or printsthe report on the color printer or on the hard drive of computer system16 at analysis unit 12. In step 484, the technician repeats the programfor all the acquired exam data.

FIG. 13 diagrammatically illustrates the review report program. In step610, a list of patients is presented to the technician. In step 612, thetechnician selects one of the patients. Decision step 614 determineswhether the technician wants to edit the data. If the YES branch istaken, a decision is made in step 616 whether the report was generatedwithin the last 48 hours. If the report is more than 48 hours old, theNO branch is taken and the technician must input his or her password inaccordance with step 618. If the password is not cleared for editing thereport more than 48 hours old, the program stops. If the password iscleared, or if the report was created within the last 48 hours, the YESbranch is taken from decision step 616 and in step 620 the OK editcommand code is set. The program returns to a point on the NO branchfrom the edit data decision step 614. In step 622, the technician ispresented with all vascular exams compiled for that patient. In thismanner, the program may call up a display screen similar to that shownin display screen 452 in FIG. 10. In step 624, the technician can scrollthrough the exam data. In step 626, the technician can turn on and offthe analog playback device. In this manner, the technician can hear theultrasound doppler signals or the audio frequency analyzer AA signals.In step 628, the technician is permitted to edit the record if the OKedit command bit is properly set. In step 630, the technician may storeand/or print the report.

FIG. 11 generally provides a flow chart for the examination unit or EUprogram. The program can be run on automatic as noted by step 710 or maybe run in a manual mode as noted by step 712. In an automaticpresentation, the EU computer system steps the operator through apredetermined number of vascular exams. Accordingly, in step 712,vascular exam 1 protocol is shown on flying display monitor 17. Thetechnician uses remote control device 41 to select instrument datasignals and the computer system in the EU 10 records those signals asdigital instrument data signals. Step 714 recognizes that the technicianis selecting digital data signals as well as inputting keypad entry datainto the RCD 41. Step 716 indicates that the vascular exam proceedsthrough exams 2, 3, 4 until the program exits.

In a manual mode, the operator in step 720 selects which vascular examhe or she is going to conduct on patient 23. In step 722, the examprotocol is displayed on display monitor 17. Control commands and keypadentry data are input by the technician in RCD 41. For long data entry,the technician may utilize keyboard 75 at the analysis unit 12.

Step 724 recognizes that the technician will acquire instrument datasignals as well as keypad entry data. Decision step 726 determineswhether other vascular exams will be conducted on patient 23. If so, theprogram reverts to a point preceding select exam step 720. If not, theNO branch is taken and the program exits.

The following paragraphs describe in greater detail the software runningon the EU computer. This software allows the operator to select and runone or more vascular studies, select a particular diagnostic test, andto execute a built-in test (BIT) of the components at the EU station.

The user interface software at the EU:(1) interprets selections madefrom the RCD 41 and then executes the appropriate function based on theselection made; (2) generates a graphical representation of theinstrument data as it is collected on the flat panel display 17,equivalent to a chart recorder hard copy; (3) records the data collectedduring a study on the AU hard drive in computer system 16 to be used togenerate the study reports; and (4) selects the appropriate audio outputgenerated from either the doppler or the Audio Analysis AA system andfeeds it to the technician's head-set 61.

After power-up and after the completion of a study, the EU will be in amode waiting for (1) a request from the AU to perform the next patientstudy; (2) for a selection from the technician to enter the free-play ormanual mode; or (3) for a selection from the technician to run thebuilt-in test. If a patient study is to be performed, then the EU willexecute the appropriate study control software module which will stepthe technician through the study with visual prompts from monitor 17 andlights on RCD 41. These modules are described earlier herein. If thetechnician selects free-play or manual mode, then any instrument can beselected and the appropriate audio and video outputs will be generatedusing the appropriate instrument routine.

If BIT is selected from the AU or EU, then a series of diagnostic testsare executed. These tests include a calibration of the OPG and verifyingcommunication with the PVR and the A/D board. If the last BIT indicatedthat some part of the equipment at the station was not functioningwithin specified parameter limits, then the user interface moduledisplays all studies requiring the use of that equipment in a differentgraphical format, indicating that they are not currently available. Oncethe BIT indicates that the equipment has returned to an operationalstatus, the studies will again be displayed as "available." BIT willalways appear as an available option.

The BIT routine performs a basic functionality check on the equipmentconnected to the EU system. It displays the items being tested on screenand indicates a pass/fail condition for each item tested. The resultsare also written to a log file with a name that includes the date onwhich the test was performed. In addition, the test results are writtento a standard file location (overwriting previous results), which theuser interface module may check to determine which options areavailable.

Study Control

The study control modules are the seven highest level modules executablein the EU. The seven available studies are as follows:

Study Table

Lower Extremity Arterial Study (LEAS)

Lower Extremity Venous Study (LEVS)

Upper Extremity Arterial Study (UEAS)

Upper Extremity Venous Study (UEVS)

Extracranial Arterial Study (EAS)

Male Impotence Study (MIS or MI Study)

Miscellaneous Studies

Each of the seven studies will electronically call some combination ofthe instrument modules described below.

LEAS

The LEAS will collect the data required for the LEAS report, using thelower PVR routine and the lower blood pressure routine.

The lower PVR module controls the lower PVR vascular exam or test. Theoperator is directed to place the cuffs in the appropriate place for alower extremities test. The lower PVR test module directs the PVRhardware to inflate the cuff. The lower PVR module then calibrates thePVR. This internal calibration is discussed earlier herein. After thePVR has been calibrated, the lower PVR module samples the cuff pressureand transfers the digitized data to the EU system. PVR results aregraphed in real time on the display during data acquisition. Thedigitized instrument data is stored.

The lower blood pressure or LBP module directs the LBP test. Theoperator is directed to place the cuffs and doppler probe in theappropriate area for a lower extremities test. The PVR hardware isdirected to inflate the cuff to a predetermined pressure to occlude thevein. The PVR outlet valve is opened to reduce the pressure quickly.When the doppler probe detects blood flow, the operator selects "recordblood pressure" from the RCD and the instrument data signal is recorded.

LEVS

The LEVS collects the data required for the LEVS report, using the lowerPVR routine and the lower venous doppler routine. The lower PVR routineis discussed above.

The lower venous doppler ultrasound or LVD module directs the LVD test.The operator is directed to place the doppler probe in the appropriatearea for a lower extremities venous test. The A/D driver module isdirected to sample the output of the doppler probe electronics. Thedigitized instrument data is then stored.

UEAS

The UEAS collects the data required for the UEAS report, using the upperPVR routine and the upper blood pressure routine respectively.

The upper PVR module directs the upper PVR test. The operator isdirected to place the cuffs in the appropriate place for an upperextremities test. The upper PVR test module directs the PVR hardware toinflate the cuff. The upper PVR module then calibrates the PVR. Afterthe PVR has been calibrated, the upper PVR module samples the cuffpressure and transfers the digitized data to the EU system. PVR resultsare graphed on the display 17 and the digitized data is stored.

The upper blood pressure or UBP module directs the UBP test. Theoperator is directed to place the cuffs and doppler probe in theappropriate area for an upper extremities test. The PVR hardware isdirected to inflate the cuff to a predetermined pressure to occlude thevein. The PVR outlet valve is opened to reduce the pressure quickly.When the doppler probe detects blood flow, the operator selects "recordblood pressure" from the RCD 41 and the signal is recorded.

UEVS

The UEVS collects the data required for the UEVS report, using the upperPVR routine and the upper venous doppler routine. The upper PVR routineis discussed above.

The upper venous doppler ultrasound or UVD module directs the UVD test.The operator is directed to place the doppler probe in the appropriatearea for an upper extremities venous test. The A/D driver module isdirected to sample the output of the doppler probe electronics. Thedigitized data is then stored.

EAS

The EAS collects the data required for the EAS report, using the upperblood pressure routine discussed above, the OPG routine, and the AAroutine.

The OPG module directs the OPG test. The operator is directed to performthe test according to manufacturer specifications. The A/D driver moduleis directed to sample the output of the OPG electronics. The OPG resultsare graphed on the display 17 and the digitized data is stored.

The audio analysis AA module directs the audio analysis test. Theoperator is directed to place the sensitive AA microphone in theappropriate area for an audio analysis test. The A/D driver module isdirected to sample the output of the Audio Analysis electronics. Theaudio analysis results are graphed on the display 17 and the digitizeddata is stored.

MI Study

The male impotence or MI Study collects the data required for the MIStudy report, using the Mean Penile Arterial Perfusion Pressure routineand the Biothesiometry routine.

The mean penile arterial perfusion pressure or MPPP module directs theMPPP test. The operator is directed to place the cuff in the appropriatearea on the penis to take the MPPP measurement and the penile systolicpressure measurement. The MPPP measurement is the maximum amplitude ofthe PVR samples taken at predefined intervals of cuff pressure. Thepenile systolic pressure measurement is taken by the PVR hardware whichis directed to inflate the cuff to a predetermined pressure. When thevalve is opened slowly, the point where blood flow is recorded is thepenile systolic pressure. The MPPP results are graphed on the displayand the measurement data is stored. Other calculated measurements, basedon the MPPP and penile systolic pressure data, are stored.

The Biothesiometry module directs the Biothesiometry test. The operatoris directed to take 5 measurements using a separate hand-held device.The operator enters the measurements that are displayed via keypad entryand this data is stored. The measurement values are compared to thenormal range of values and an indication of "normal" or "abnormal" isdisplayed.

Miscellaneous Studies

The Miscellaneous Studies allow the operator to use a specificinstrument at a specific area on the patient, e.g., perform a PVRmeasurement on the patient's left ankle. This routine calls therespective instrument routine as described herein.

The following are additional lower and upper extremity tests. The lowerPPG module directs the LPPG test. The operator is directed to place thePPG in the appropriate area for a lower extremities PPG test. The A/Ddriver module is directed to sample the output of the PPG electronics.The PPG results are graphed on the display and the digitized data isstored.

The upper PPG module directs the UPPG test. The operator is directed toplace the PPG in the appropriate area for an upper extremities PPG test.The A/D driver module is directed to sample the output of the PPGelectronics. The PPG results are graphed on the display and thedigitized data is stored.

Data Formatting

The data formatting routines convert/translate the raw data receivedfrom the instrument routines into various disk storage formats. Datafrom all instruments is stored in tabular ASCII format. No processing isperformed on the data by these routines. Data selection and manipulationare performed during report generation at the AU system.

FIG. 14 diagrammatically illustrates the peripheral vascular lab PVLentity relationship diagram. The arrows in FIG. 14 indicate hierarchy orpriority for those data functions. For example, with respect to patientblock 810, data must be entered into that functional routine prior toinitiating male impotence MI surgical procedures 812 and prior toinitiating study link 814. The patient functional block includes thefollowing information:

Patients

SSN/Patient ID: Text(11)

LastName: Text(50)

FirstName: Text(50)

MI: Text(1)

Sex: Text(1)

Date Entered: Date/Time

DOB: Date/Time

PriorEvaluation: Date/Time

This patient entry function includes keypad entry data representing thepatient's social security number, his or her last name, first name,middle initial identifier (a single bit of text), sex, date and time,date of birth and date of prior evaluation.

The study link functional block 814 includes the following items:

Study Link

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Referring Physician: Text(50)

Examined By: Text(50)

Report Code: Text(15)

Word File Path: Text(50)

Analyzed Data: Yes/No

Study link functional block 814 has priority or is superior over themedical reports functional block 816. The medical reports block includesthe following information:

Medical Reports

Report Code: Text(15)

Report Name: Text(50)

Corr Form Name: Text(70)

The information in the history and physical findings functional block820, the general vascular history functional block 822, the extracranialvascular history block 824 and the arterial vascular history functionalblock 826 are all entered via the keypad in a keypad entry data. Theinformation entered via keyboard 75 on analysis unit 12 or RCD keypad 41is identified in the following tables:

History and Physical Findings

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Recent Trauma Right: Text(2)

Recent Trauma Left: Text(2)

Edema Right: Text(2)

Edema Left: Text(2)

Calf Tenderness Right: Text(2)

Calf Tenderness Left: Text(2)

Arm Tenderness Right: Text(2)

Arm Tenderness Left: Text(2)

Skin Changes Right: Text(2)

Skin Changes Left: Text(2)

Varicose Veins Right: Text(2)

Varicose Veins Left: Text(2)

Previous DVY Right Upper: Text(2)

Previous DVY Left Upper: Text(2)

Previous DVY Right Lower: Text(2)

Previous DVY Left Lower: Text(2)

Pleural Discomfort: Text(2)

Hormone Use: Text(2)

Hypercoagulability: Text(2)

Malignant Disease: Text(2)

CVA: Text(2)

CHF: Text(2)

Other: Text(2)

S/P and Notes: Memo

General Vascular History

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Cigarette Smoking: Text(10)

Hypertension: Text(2)

Diabetes: Text(9)

Hypertipidemia: Text(2)

Obesity: Text(2)

Angina: Text(2)

MI: Text(2)

CVA: Text(2)

Claudication: Text(2)

Headache: Text(2)

Dysphasia: Text(2)

Syncope: Text(2)

Vertigo: Text(2)

Dizziness: Text(2)

Amaurosis Fugax: Text(2)

Hemiplegia: Text(2)

Asymptomatic: Text(2)

TIA: Text(2)

S/P and Notes: Memo

Vascular Skin Lesions: Text(200)

Resting Symptoms: Text(200)

Exertional Symptoms: Text(200)

Extracranial Vascular History

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Claudication: Text(2)

Headache: Text(2)

Dysphasia: Text(2)

Syncope: Text(2)

Vertigo: Text(2)

Dizziness: Text(2)

Amaurosis Fugax: Text(2)

Hemiplegia: Text(2)

Asymptomatic: Text(2)

TIA: Text(2)

S/P and Notes: Memo

Arterial Vascular History

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Vascular Skin Lesions: Text(200)

Resting Symptoms: Text(200)

Exertional Symptoms: Text(200)

S/P and Notes: Memo

In contrast to functional blocks 820-826, the venous hemodynamicfunctional block 828 stores both a keypad entry data as well as waveformdata or digital instrument data signals obtained from the pulse volumerecorder PVR.

Venous Hemodynamic

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Right MVO: Double

Left MVO: Double

Right SVC: Double

Left SVC: Double

Particularly, a directory on the computer system is made for eachpatient. In this directory, text data is put in certain files. Otherfiles hold waveform data in various sub-directories. This waveform dataor other types of digital instrument data signals are linked to thekeypad entry data with the appropriate electronic linkage commands.

The exercise evaluation functional block 830 includes the followingkeypad entry data:

Exercise Evaluation

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Maximum Walking Time: Single

Rate: Single

Grade: Single

Symptoms with Exercise: Memo

Symptoms at Time1: Single

Symptoms at Time2: Single

Symptoms at Time3: Single

Symptoms 1: Memo

Symptoms 2: Memo

Symptoms 3: Memo

Right Bilateral Ankle Sys Pressure: Text(5)

Left Bilateral Ankle Sys Pressure: Text(5)

Brachial Systolic Pressure: Text(5)

Right Femoral Bruits: Yes/No

Left Femoral Bruits: Yes/No

The venous doppler exam functional block 832 includes a reasonably largeamount of digital instrument data signals. As discussed earlier, thedoppler ultrasound probe detects blood flow through veins and arteriesof the patient. Upon the proper command by the technician, the digitalinstrument data signals obtained from the analog doppler signals areinitially stored in the examination unit. The venous doppler exam tableset forth below identifies data fields. As is common, a byte is an 8-bitdata field.

Venous Doppler Exam

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Common Femoral Spontaneous R: Byte

Common Femoral Spon taneous L: Byte

Common Femoral Phasic R: Byte

Common Femoral Phasic L: Byte

Common Femoral Augmented R: Byte

Common Femoral Augmented L: Byte

Common Femoral Competent R: Byte

Common Femoral Competent L: Byte

Common Femoral Nonpulsable R: Byte

Comm on Femoral Nonpulsable L: Byte

Popliteal Spontaneous R: Byte

Popliteal Spon taneous L: Byte

Popliteal Phasic R: Byte

Popliteal Phasic L: Byte

Popliteal Augmented R: Byte

Popliteal Augmented L: Byte

Popliteal Competent R: Byte

Popliteal Competent L: Byte

Popliteal Nonpulsable R: Byte

Popliteal Nonpulsable L: Byte

Posterior Tibial Spontaneous R: Byte

Posterior Tibial Spontaneous L: Byte

Posterior Tibial Phasic R: Byte

Posterior Tibial Phasic L: Byte

Posterior Tibial Augmented R: Byte

Posterior Tibial Augmented L: Byte

Posterior Tibial Competent R: Byte

Posterior Tibial Competent L: Byte

Posterior Tibial Nonpulsable R: Byte

Posterior Tibial Nonpulsable L: Byte

Superficial Femoral Spontaneous R: Byte

Superficial Femoral Spontaneous L: Byte

Superficial Femoral Phasic R: Byte

Superficial Femoral Phasic L: Byte

Superficial Femoral Augmented R: Byte

Superficial Femoral Augmented L: Byte

Superficial Femoral Competent R: Byte

Superficial Femoral Competent L: Byte

Superficial Femoral Nonpulsable R: Byte

Superficial Femoral Nonpulsable L: Byte

Greater Saphenous Spontaneous R: Byte

Greater Saphenous Spontaneous L: Byte

Greater Saphenous Phasic R: Byte

Greater Saphenous Phasic L: Byte

Greater Saphenous Augmented R: Byte

Greater Saphenous Augmented L: Byte

Greater Saphenous Competent R: Byte

Greater Saphenous Competent L: Byte

Greater Saphenous Nonpulsable R: Byte

Greater Saphenous Nonpulsable L: Byte

Brachial Spontaneous R: Byte

Brachial Spontaneous L: Byte

Brachial Phasic R: Byte

Brachial Phasic L: Byte

Brachial Augmented R: Byte

Brachial Augmented L: Byte

Brachial Competent R: Byte

Brachial Competent L: Byte

Brachial Nonpulsable R: Byte

Brachial Nonpulsable L: Byte

The continuous wave doppler function 834 also stores digitalrepresentations of the instrument data signal obtained from the dopplerprobe.

Continuous Wave Doppler Exam

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Supraorbital Left: Integer

Supraorbital Right: Integer

Temporal Compression Left: Integer

Temporal Compression Right: Integer

Facial Compression Left: Integer

Facial Compression Right: Integer

Proximal Left: Integer

Proximal Right: Integer

Distal Left: Integer

Distal Right: Integer

Commonly, the technician will initially select about ten seconds of thedoppler signal. He or she does this by listening to the playback of theanalog signals on headset 61. When the technician finds an acceptablesignal, he or she selects the record button on RCD 41. The computersystem in the examining unit then records about ten seconds of thatsignal. Simultaneously, that signal may be displayed on flying monitor17. After the exam is completed, the technician then goes to analyzingunit 12. While generating the report with keypad 75 and monitor 73, thetechnician can listen to that ten second initially acquired signal andfurther select three seconds of the continuous wave doppler signal. Itis that three second signal that is electronically linked with thevascular diagnostic reports. As discussed later herein, the electronicversion of the vascular diagnostic report as well as the digitalrepresentation of that analog doppler signal can be transmitted across atelecommunications network. This enables the referring physician to notonly see the electronic version or the printed out version of thereport, but also hear the analog version of the recorded doppler exam.This ability to record not only text and integrate the keypad entry dataalong with the digital representation of the analog is an importantfeature of the present invention.

The carotid pulse palpation function step 836, the arterial pulsepalpation step 838, and the upper arterial pulse palpation function 840are all essentially keypad entry data.

Carotid Pulse Palpation

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Common Carotid Right: Text(10)

Common Carotid Left: Text(10)

Temporal Right: Text(10)

Temporal Left: Text(10)

Facial Right: Text(10)

Facial Left: Text(10)

Carotid Bruits Right: Yes/No

Carotid Bruits Left: Yes/No

Temporal Bruits Right: Yes/No

Temporal Bruits Left: Yes/No

Facial Bruits Right: Yes/No

Facial Bruits Left: Yes/No

Arterial Pulse Palpation

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Femoral Right: Text(3)

Femoral Left: Text(3)

Popliteal Right: Text(3)

Popliteal Left: Text(3)

Anterior Tibial Right: Text(3)

Posterior Tibial Right: Text(3)

Anterior Tibial Left: Text(3)

Posterior Tibial Left: Text(3)

Femoral Bruits Right: Yes/No

Femoral Bruits Left: Yes/No

Femoral Doppler Right: Integer

Femoral Doppler Left: Integer

Popliteal Doppler Right: Integer

Popliteal Doppler Left: Integer

Anterior Tibial Doppler Right: Integer

Posterior Tibial Doppler Right: Integer

Anterior Tibial Doppler Left: Integer

Posterior Tibial Doppler Left: Integer

Upper Arterial Pulse Palpation

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Carotid Pulse Left: Text(3)

Carotid Pulse Right: Text(3)

Subclavian Pulse Left: Text(3)

Subclavian Pulse Right: Text(3)

Axiliary Pulse Left: Text(3)

Axiliary Pulse Right: Text(3)

Brachial Pulse Left: Text(3)

Brachial Pulse Right: Text(3)

Radial Pulse Left: Text(3)

Radial Pulse Right: Text(3)

Ulnar Pulse Left: Text(3)

Ulnar Pulse Right: Text(3)

Carotid Bruits Left: Yes/No

Carotid Bruits Right: Yes/No

Subclavian Bruits Left: Yes/No

Subclavian Bruits Right: Yes/No

Carotid DS Left: Integer

Carotid DS Right: Integer

Subclavian DS Left: Integer

Subclavian DS Right: Integer

Axiliary DS Left: Integer

Axiliary DS Right: Integer

Brachial DS Left: Integer

Brachial DS Right: Integer

Radial DS Left: Integer

Radial DS Right: Integer

Ulnar DS Left: Integer

Ulnar DS Right: Integer

The carotid audio frequency data function 842, the lower arterial PVRfunction 846 and the upper arterial PVR function 848 involve the storageof keypad entry data, but primarily involve the storage of digitalversions of waveforms corresponding to sound or audio (for the audiofrequency data) or waveforms in the form of the electronic output of aPVR.

Carotid Audiofrequency Data

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Cardiac Murmur: Yes/No

Subclavian Bruit: Yes/No

CAA1 Right: Yes/No

CAA2 Right: Yes/No

CAA3 Right: Yes/No

CAA4 Right: Yes/No

CAA5 Right: Yes/No

CAA1 Left: Yes/No

CAA2 Left: Yes/No

CAA3 Left: Yes/No

CAA4 Left: Yes/No

CAA5 Left: Yes/No

Lower Arterial PVR

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Right Thigh Psys: Text(5)

Left Thigh Psys: Text(5)

Right Calf Psys: Text(5)

Left Calf Psys: Text(5)

Right Ankle Psys: Text(5)

Left Ankle Psys: Text(5)

Upper Arterial PVR

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Right Upper Arm Psys: Integer

Left Upper Arm Psys: Integer

Right Forearm Psys: Integer

Left Forearm Psys: Integer

The OPG contraindications function block 850 is a text based date entryand the OPG data function block 852 is a waveform or digitalrepresentation of an analog signal data entry.

OPG Contraindications

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Contraindications: Yes/No

Glaucoma: Yes/No

Conjunctivitis: Yes/No

Eye Trauma: Yes/No

Allergic: Yes/No

OPG Data

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Ophthalmic Artery Left: Integer

Ophthalmic Artery Right: Integer

The PPG function block 860 represents both text but primarily waveformdata.

PPG

SSN/Patient ID: Text(11)

Date/Time: Date/Time

PPG Location: Text(50)

The male impotence MI function blocks are: MI surgical procedures 812,MI results 870, RigiScan function 872, serum evaluation 874, MI history876, MI pulse 878 and MI medications 880 as well as MI biothesiometry890 and MI arterial penile perfusion 892. These are currently keypaddata entry. However, the MI arterial penile perfusion is a keypad entryor single number which is calculated based upon certain PVR values. Thisis discussed above in connection with the corresponding module.

MI Surgical Procedures

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Procedure Name: Text(200)

MI Results

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Medical Consistent: Text(3)

Sexual History Consistent: Text(3)

RigiScan Findings: Text(3)

Arterial Penile Perfusion Measurements: Text(3)

Biothesiometry Results: Text(3)

Serum Evaluation: Text(3)

RigiScan

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Date 1: Date/Time

Date 2: Date/Time

Time 1: Single

Time 2: Single

Number of events 1: Text(15)

Number of events 2: Text(15)

Resting Tumescence 1: Text(7)

Resting Tumescence 2: Text(7)

Tip Increase 1: Text(7)

Tip Increase 2: Text(7)

Base Increase 1: Text(7)

Base Increase 2: Text(7)

Max Duration 1: Integer

Max Duration 2: Integer

Average Duration 1: Integer

Average Duration 2: Integer

Max Rigidity 1: Integer

Max Rigidity 2: Integer

Dissociation 1: Integer

Dissociation 2: Integer

Uncoupling 1: Integer

Uncoupling 2: Integer

Plots Attached: Yes/No

Serum Evaluation

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Glucose Fasting: Integer

TST: Integer

Prolactin: Double

LH: Double

Lab: Text(25)

Office: Text(25)

Other: Text(25)

MI Biothesiometry

SSN/Patient ID: Text(11)

Date/Time: Date/Time

MI Age: Byte

1st Digit Right: Byte

1st Digit Left: Byte

Shaft Right: Byte

Shaft Left: Byte

Glans: Byte

MI Medications

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Name: Text(100)

Dose: Text(50)

When Taken: Text(50)

MI Arterial Penile Perfusion

SSN/Patient ID: Text(11)

Date/Time: Date/Time

MPPP: Integer

Penile Systolic Pressure: Integer

PVR Amplitude: Integer

MI History

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Q1: Text(200)

Q2a: Byte

Q2b: Byte

Q3: Date/Time

Q4: Byte

Q5: Text(200)

Q6a: Yes/No

Q6b: Text(25)

Q6c: Byte

Q7a: Yes/No

Q7b: Text(25)

Q7c: Byte

Q8a: Yes/No

Q8b: Yes/No

Q8c: Yes/No

Q8d: Yes/No

Q8e: Yes/No

Q8f: Byte

Q9a: Yes/No

Q9b: Text(25)

Q10a: Byte

Q10b: Text(200)

Q11a: Byte

Q11b: Text(200)

Q11c: Date/Time

Q12: Date/Time

Q13a: Yes/No

Q13b: Byte

Q13c: Byte

Q14a: Yes/No

Q14b: Byte

Q14c: Date/Time

Q15a: Yes/No

Q15b: Date/Time

Q16a: Yes/No

Q16b: Text(200)

Q17a: Yes/No

Q17b: Text(200)

Q18a: Yes/No

Q18b: Text(200)

Q19a: Yes/No

Q19b: Yes/No

Q19c: Yes/No

Q19d: Yes/No

Q19e: Yes/No

Q20a: Yes/No

Q20b: Yes/No

Q20c: Yes/No

MI Pulse

SSN/Patient ID: Text(11)

Date/Time: Date/Time

Carotid Pulse Left: Text(3)

Carotid Pulse Right: Text(3)

Brachial Pulse Left: Text(3)

Brachial Pulse Right: Text(3)

Abd Aorta Pulse: Text(3)

Femoral Pulse Left: Text(3)

Femoral Pulse Right: Text(3)

POP Pulse Left: Text(3)

POP Pulse Right: Text(3)

DP Pulse Left: Text(3)

DP Pulse Right: Text(3)

PT Pulse Left: Text(3)

PT Pulse Right: Text(3)

Carotid Bruits Left: Yes/No

Carotid Bruits Right: Yes/No

Abd Aorta Bruits: Yes/No

Femoral Bruits Left: Yes/No

Femoral Bruits Right: Yes/No

Carotid Doppler Signal Left: Integer

Carotid Doppler Signal Right: Integer

Brachial Doppler Signal Left: Integer

Brachial Doppler Signal Right: Integer

Femoral Doppler Signal Left: Integer

Femoral Doppler Signal Right: Integer

POP Doppler Signal Left: Integer

POP Doppler Signal Right: Integer

DP Doppler Signal Left: Integer

DP Doppler Signal Right: Integer

PT Doppler Signal Left: Integer

PT Doppler Signal Right: Integer

Lower Extremity Eval: Yes/No

Lower Extremity Eval Date: Date/Time

In the current embodiment, the RigiScan function 872 is currently inputas keypad entry data. However, in the future, it will be possible toprovide an electronic port through an RS232 electronic linkage such thatdata compiled by a portable RigiScan device can be electronicallydownloaded into the RigiScan function 872.

In addition to the foregoing, the following tables identify electronicstorage areas for medical forms, institution information and SVCRcurves.

Medical Forms

Med Form Code: Text(15)

Med Form Sequence: Byte

Med Form Full Name: Text(70)

Med Sub Link Child: Text(50)

Med Sub Link Parent: Text(50)

Med Label: Text(50)

Institution

Name: Text(100)

Address: Text(50)

City: Text(50)

State: Text(50)

Zip: Text(10)

Phone: Text(12)

Fax: Text(12)

Stenographer: Text(50)

SVCR Curve

SVCR: Double

Venous Evaluation Points V2: Double

As used herein, the term "database" is a set of interrelated files thatis created and managed either by a database management system or the"database" is simply an electronically stored collection of data. All ofthis data, whether keypad entry data or digital instrument data signals(that is, the data signals obtained by the medical instruments which areconverted into digital format), is interrelated based upon the entityrelationship diagram shown in FIG. 14 and as further identified in thetables discussed herein. Since a database is utilized to interrelate andcollect all this electronic data, it is also known that a spreadsheetcould be utilized. As used herein, the term "database" includes adatabase as managed by a database management system, a spreadsheet andany other electronic linking of data.

Important features of the present invention are interrelation of thekeypad entry data and the digital instrument data signals, enabling thetechnician to easily gather this data from the patient, and theproduction of vascular diagnostic reports without significantintervention by the technician. The reports are electronically generatedbased upon earlier acquired data.

FIGS. 15-39 diagrammatically illustrate vascular diagnostic reportscompiled by the keypad entry data as well as the digital instrumentdata. These reports are generally standard in the industry, however, thepresent invention is the first device which integrates and generatesthese reports based upon a database compilation of keypad entry data anddigital instrument data signals.

FIGS. 15-18 provide an arterial evaluation of the lower extremitiesutilizing the integrated peripheral vascular diagnostic system. As shownin FIG. 15, patient identification is shown in the upper region of theelectronic form which is displayed to the technician on monitor 73.Other keypad entry data is obtained from the patient and logged into thevascular history portion of the report on FIG. 15. The arterial pulsedata is keypad entry data obtained by the technician and entered via RCD41. The doppler signals and the check marks on the lower region of thereport indicate that the technician believes that those ultrasonicdoppler signals are proper. When the technician prepares this report asdiscussed earlier herein, the technician could be wearing headphones 61and listen to the doppler signals. It is an important feature of thepresent invention to visually present both the electronic version ofthis report shown in FIG. 15 as well as to enable the technician or theexamining physician to listen to the doppler signals via headphones 61at the same time as he or she looks at the electronic report. Of course,the vascular diagnostic report can be printed in color on printer 79 atthe same time as the physician or technician listens to the dopplersignal on headphones 61.

FIG. 16 shows a vascular diagnostic report revealing a printed outversion of the analog signal obtained by the PVR. FIG. 17 also shows aprinted out version of the analog signal. Of course, the electronicdigital instrument data signal corresponding to this printout of theanalog signal are electronically stored and linked with the electronicversion of this report in the analysis unit 12.

Currently, at the end of the vascular examination by examining unit 10,the data is electronically transferred to computer system 16 ofanalyzing unit 12. By providing both the electronic version of thesignals displayed in FIG. 17, with the printed out copy as well as theelectronic form copy, the referring physician can further study thevascular condition of his or her patient.

FIG. 18 diagrammatically illustrates not only keypad entry datainvolving the exercise evaluation but also analog data showing PVRsignals after the exercise.

FIG. 19 diagrammatically illustrates how the record can be altered byshowing an amputation. The pitchfork lines 901 and 903 can be moved bythe technician during the preparation of the report. This is done byclick and point and the particular software on the analysis unit.Accordingly, the technician or other physician can annotate theelectronic record simply by moving symbols 901 and 903 to any point oneither of the left or right legs.

FIG. 20 shows the ability of the technician or physician to furtherannotate the electronic record by identifying lesions or other items onthe graphic representations of the left and right foot.

FIG. 21 provides another graphic representation of the foot which can beanalyzed by analysis unit 12.

FIG. 22 diagrammatically illustrate the arterial evaluation of lowerextremities. The technician or physician can move the residuallumen/calcification symbol, the soft plaque symbol, the smooth marginssymbol, the irregular margins symbol, the ulceration margins symbol andthe absorption symbol to any location on the graphic representation 903of the vein or artery. In this manner, the electronic record can beamplified and annotated based upon the particular findings noted by thetechnician during the vascular exam.

FIGS. 23-30 diagrammatically illustrate the electronic output forms forvascular diagnostic report involving male impotence MI. FIGS. 23, 24 and25 diagrammatically illustrate keypad entry data in a form that can beused as part of a vascular analysis of male impotence. FIG. 26 is agraphic representation showing the keypad entry data from the technicianas well as an indication that certain ultrasound doppler signals wereobtained and considered normal by the technician. FIG. 27 graphicallyillustrates the mean penile arterial perfusion pressure which is a PVRanalog signal. Further data, either keypad entry data or data calculatedbased on certain PVR values, are shown in FIG. 27. FIG. 28 is abiothesiometry table correlating vascular analysis of the fingers, thepenis and the glans.

FIG. 29 represents the vascular diagnostic report for a RigiScan data.As discussed earlier, this data could be keypad entry data or could beelectronically downloaded from a RigiScan device. The serum evaluationis keypad entry data which is based upon an analysis of the semen of themale patient.

FIG. 30 presents a graphical representation providing an initialvascular analysis of the male impotence. Abnormal findings are indicatedwith a plus sign, normal findings are indicated by a negative sign, andUKN indicates unknown. FIGS. 31-34 diagrammatically illustrate a venousevaluation of lower extremities. FIG. 31 shows generally keypad entrydata. FIG. 32 shows not only the data for the machine setting but alsoanalog data representing a PVR recording. FIG. 33 shows the ultrasounddoppler exam and an indication by the technician whether that dopplerexam was present, reduced or absent. The hemodynamic summary showsanalog representations of the SCVR curve and the MVO curve.

FIG. 34 shows a venous evaluation point.

FIG. 35 is associated with the venous evaluation. The technician canannotate the graphic representation shown in FIG. 35 to indicate anyproblems.

FIGS. 36-39 relate to the carotid evaluation. FIG. 36 shows keypad entrydata involving patient information, vascular history as well as a pulseanalysis for the brachial blood pressure. FIG. 37 shows the OPGcontraindications that the technician must complete prior to initiatingthe OPG test. If one of the indications is identified by the technician,the vascular diagnostic system will not permit the OPG test. Since nocontraindications were indicated, the technician obtained the instrumentdata from the OPG. FIG. 37 shows the printed out analog version of theophthalmic artery pressure.

FIG. 38 shows a carotid audio frequency analysis CAA. When viewing thiselectronic form, the technician could select a playback button andlisten to the audio frequency as actually recorded during the exam. Thelower portion of FIG. 38 shows the continuous wave doppler exam results.FIG. 39 graphically shows a carotid artery. The technician, in compilinghis or her vascular diagnostic report, could move the symbols forresidual lumen/calcification, soft plaque, smooth margins, irregularmargins, ulceration margins and absorption to any location on thecarotid artery image 905. When stored with the recorded vascular form,that carotid image could be transferred to the referring physician forhis or her further review.

Other forms could be utilized with the integrated peripheral vasculardiagnostic system. The forms identified and discussed herein areexemplary in nature.

FIG. 40 diagrammatically illustrates the integrated vascular diagnosticsystem on a cart 1010. Monitor 1012 is on the top of the cart. Akeyboard 1014 and a remote control device 1016 are on the first shelf.On the second shelf, a color printer 1018 and a test port panel 1047 islocated. As discussed earlier in connection with FIG. 1 and the otherfigures, various pressure cuffs, doppler probes, microphones, and otherequipment can be plugged into test port panel 1047. The computer system1050 can prompt the technician to gather vascular data. When thevascular exam is completed, the technician can analyze that data usingkeyboard 1014 and a mouse or track ball (not shown in FIG. 40).Headphones 1060 can be utilized to play back and listen to the dopplerultrasound signals as well as the audio frequency sound signals. Printedreports can be provided by printer 1018. As is known, the electronicversion of the reports could be downloaded from computer system 1050into a larger computer system for further study by the referringphysician or another vascular physician.

The claims appended hereto are meant to cover modifications and changeswithin the spirit and scope of the present invention.

What is claimed is:
 1. An integrated, peripheral vascular diagnosticsystem electronically linking a doppler ultrasound unit generatingultrasound doppler data signals and at least one from the groupconsisting of a pulse volume recorder (PVR), an ocularpneumoplethysmograph (OPG), a photoplethysmograph (PPG), and an audiofrequency analysis (AA) unit, each respectively generating PVR, OPG,PPG, and AA data signals, the integrated diagnostic systemcomprising:means for electronically acquiring and converting saiddoppler data signals into an initial set of digital data signals; acomputer system including a processor, a memory, a keypad input device,a display monitor, a printer and means for interfacing together saidprocessor, said memory, said keypad, said display monitor, said printerand said means for acquiring and converting said data signals; a datacompilation means, incorporated into said computer system, for compilingand initially storing said initial set of digital data signals andpatient data into said memory substantially concurrently with theacquisition of said doppler data signals, said patient data entered intosaid computer system via said keypad; a report generator means, as partof said computer system, for generating at a time subsequent to theinitial storage of said initial set of digital data signals and notduring data acquisition, and displaying at said time subsequent, andprinting at said time subsequent, a plurality of vascular diagnosticreports based upon said digital data signals and said patient data; ananalog playback means, as part of said report generator means, forpresenting a visual analog version of at least some of said initial setof digital data signals and an audio analog version of at least some ofsaid initial set of digital data signals; and, means for selecting,during the presentation, a portion of said stored initial set of digitaldata signals to be included in said vascular diagnostic report.
 2. Anintegrated vascular diagnostic system as claimed in claim 1, whereinsaid respective data signals are instrument data signals, and saidsystem includes means for converting said instrument data signals intofurther digital data signals and displaying, selecting and printingselected portions of the further digital data signals via said reportgenerator means.
 3. An integrated vascular diagnostic system as claimedin claim 1, wherein said report generator means includes means forstoring said vascular diagnostic report with said selected portion ofdigital data signals.
 4. An integrated vascular diagnostic system asclaimed in claim 1, wherein said data signals are instrument datasignals representing a plurality of waveforms, said means for acquiringand converting generating further digital data signals based thereon andrepresenting corresponding waveforms, and said report generator meansincludes means for converting said initially stored digital data signalsand further digital data signals into analog displays of saidcorresponding waveforms.
 5. An integrated vascular diagnostic system asclaimed in claim 1, wherein said playback means includes an audio systemfor listening to said analog version of said doppler data signalsrepresented in part by said digital data signals during the display ofsaid diagnostic reports by said report generator means.
 6. An integratedvascular diagnostic system as claimed in claim 2, wherein said audiosystem includes one of headphone set and a speaker.
 7. An integratedvascular diagnostic system as claimed in claim 1, wherein said datacompilation means includes a data base manager program.
 8. An integratedvascular diagnostic system as claimed in claim 2, wherein said playbackmeans includes an audio system for listening to an analog version ofsaid digital data signals and said further digital data signals.
 9. Anintegrated vascular diagnostic system as claimed in claim 8, whereinsaid audio system includes a headphone set and said headphone setincludes a radio frequency (RF) receiver, and said playback meansincludes means for transmitting said analog version of said digital datasignals or said further digital data signals to said RF receiver.
 10. Anintegrated vascular diagnostic system as claimed in claim 1, whereinsaid computer system includes a network port for enablement of atelecommunications link and a transfer of said digital data and saidkeypad entry data.
 11. An integrated vascular diagnostic system asclaimed in claim 9, wherein said computer system includes a network portfor enablement of a telecommunications link and a transfer of saiddigital data and said keypad entry data.
 12. An integrated vasculardiagnostic system as claimed in claim 11, wherein said report generatorand said means for selecting portions of said digital data signalsincludes means for reorganizing data into a plurality of electronicoutput forms, said report generator displaying and printing analogrepresentations of said selected digital data and said reorganized dataas said plurality of output forms.
 13. An integrated vascular diagnosticsystem as claimed in claim 1, wherein said system includes a cart whichcarries said computer system.
 14. An integrated vascular diagnosticsystem as claimed in claim 1, wherein said means for selecting includesmeans for scrolling through said stored initial set of digital data. 15.An integrated vascular diagnostic system as claimed in claim 2, whereinsaid means for selecting includes means for scrolling through saidfurther digital data signals.
 16. An integrated vascular diagnosticsystem as claimed in claim 1, wherein said system includes means forprompting the acquisition of at least one of said doppler data signalsand said respective data signals, said means for prompting incorporatedinto said computer system and operative in conjunction with said displaymonitor.
 17. An integrated, peripheral vascular diagnostic systemutilizing patient data and electronically linking a doppler ultrasoundunit generating ultrasound doppler data signals and at least one fromthe group consisting of a pulse volume recorder (PVR), an ocularpneumoplethysmograph (OPG), a photoplethysmograph (PPG), and an audiofrequency analysis (AA) respective unit, each respectively generatingPVR, OPG, PPG, and AA data signals, at least one of said doppler datasignals and said respective data signals having an audio characteristic,the integrated diagnostic system comprising:means for electronicallyacquiring and converting said data signals into an initial set ofdigital data signals; a computer system including a processor, a memory,a keypad input device, a display monitor, a print unit and means forinterfacing together said processor, said memory, said keypad, saiddisplay monitor, said print unit and said means for acquiring andconverting said data signals; a data compilation means, incorporatedinto said computer system for compiling and initially storing saidinitial set of digital data signals and said patient data into saidmemory; a report generator means, as part of said computer system, forgenerating at a time subsequent to the initial storage of said initialset of digital data signals and not during data acquisition, displayingat said time subsequent, and printing at said time subsequent aplurality of vascular diagnostic reports based upon said digital datasignals and said patient data; an analog playback means, as part of saidreport generator means, for presenting both a visual analog version ofat least some said initial set of digital data signals and an audioanalog version of at least some of said initial set of digital datasignals having said audio characteristic; and, means for selecting,during the presentation, a portion of said stored initial set of digitaldata signals to be included in said vascular diagnostic report.
 18. Anintegrated vascular diagnostic system as claimed in claim 17, whereinsaid data signals include instrument data signals and doppler datasignals, at least one of which has said audio characteristic, and saidsystem includes means for linking the audio characteristic data signalswith corresponding patient data and said selected portion of saiddigital data signals via said report generator means.
 19. An integratedvascular diagnostic system as claimed in claim 17, wherein said dopplerdata signal has said audio characteristic and said analog playback meansis utilized substantially concurrently with said means for selecting tostore said selected portion of said data signal with said diagnosticreport.
 20. An integrated vascular diagnostic system as claimed in claim18, wherein said instrument data signals include a plurality ofwaveforms, said digital data signals from said means for acquiring andconverting represent corresponding waveforms based upon said instrumentdata signals, and said report generator means includes means forconverting said corresponding initially stored digital data signals intoanalog displays and prints of said corresponding waveforms.
 21. Anintegrated vascular diagnostic system as claimed in claim 17, whereinsaid playback means includes one of a speaker and a headphone set forlistening to said analog version of said digital data or doppler datasignals during the display of said diagnostic reports by said reportgenerator means.
 22. An integrated vascular diagnostic system as claimedin claim 17, wherein said print unit electronically prints and storessaid diagnostic reports in said memory with said diagnostic report. 23.An integrated vascular diagnostic system as claimed in claim 21, whereinsaid playback means includes headphones and said headphones furtherinclude a radio frequency (RF) receiver, and said playback meansincludes means for transmitting said analog version of said digital datasignals or doppler data signals to said RF receiver.
 24. An integratedvascular diagnostic system as claimed in claim 17, wherein said computersystem includes a network port for enablement of a telecommunicationslink and transfer of at least one of said digital data and said dopplerdata and said diagnostic report.
 25. An integrated vascular diagnosticsystem as claimed in claim 20, wherein said report generator and saidmeans for selecting portions of said initial set of digital data signalsincludes means for reorganizing said patient data and said selectedportions of digital data signals into a plurality of electronic outputforms, said report generator displaying and printing analogrepresentations of said selected digital data and said patient data assaid plurality of output forms.
 26. An integrated vascular diagnosticsystem as claimed in claim 17, wherein said system includes a cart whichcarries said computer system.
 27. An integrated vascular diagnosticsystem as claimed in claim 17, wherein said means for selecting includesmeans for scrolling through said stored initial set of digital data. 28.An integrated vascular diagnostic system as claimed in claim 18, whereinsaid means for selecting includes means for scrolling through saiddigital data signals.
 29. An integrated vascular diagnostic system asclaimed in claim 17, wherein said system includes means for promptingthe acquisition of at least one of said doppler data signals and saidrespective data signals, said means for prompting incorporated into saidcomputer system and operative in conjunction with said display monitor.30. A method for electronically integrating a vascular diagnostic systemby electronically linking patient data, a doppler ultrasound unitgenerating ultrasound doppler data signals and at least one from thegroup consisting of a pulse volume recorder (PVR), an ocularpneumoplethysmograph (OPG), a photoplethysmograph (PPG), and an audiofrequency analysis (AA) unit, each respectively generating PVR, OPG,PPG, and AA data signals, the method comprising the stepsof:electronically acquiring and converting said doppler data signalsinto an initial set of digital data signals; compiling and initiallystoring said initial set of digital data signals and said patient datainto a data base, said initial storage of said initial set of digitaldata occurring substantially concurrently with the acquisition of saidinstrument data signals; generating and displaying, at a time subsequentto said initial digital data storage and not during data acquisition,and printing a plurality of vascular diagnostic reports based upon saiddigital data signals and said patient data, at least a portion of saiddisplay and printing including the display and printing of analogrepresentations of said digital data, the step of generating includingthe step of selecting a portion of said initial set of digital datarepresenting said doppler data signals and subsequently storing saidportion of digital data as part of said vascular diagnostic reports; andpresenting both a visual analog version of at least some of said initialset of digital data signals and an audio analog version of at least someof said initial set of digital data signals substantially during thestep of selecting.
 31. A method as claimed in claim 30, including thestep of audibly presenting analog representations of digital datasubstantially simultaneous with the visual display of said digital data.32. A method as claimed in claim 31, including the step of reorganizingsaid patient data into a plurality of electronic output forms whichrepresent said vascular diagnostic reports.
 33. A method as claimed inclaim 32, including the step of electronically transmitting saidvascular diagnostic reports and said digital data outbound from saidvascular diagnostic system.
 34. A method as claimed in claim 30,including the step of scrolling through said initial set of digital datasignals during the step of selecting.
 35. A method as claimed in claim30, including the step of prompting an input of at least one of saiddoppler data signals and said respective data signals.
 36. A method asclaimed in claim 30, including the step of audibly announcing said audioanalog version of said initial set of digital data signals into anambient environment during the step of presenting.
 37. A method forelectronically integrating a vascular diagnostic system byelectronically linking a doppler ultrasound unit generating ultrasounddoppler data signals and at least one from the group consisting of apulse volume recorder (PVR), an ocular pneumoplethysmograph (OPG), aphotoplethysmograph (PPG), and an audio frequency analysis (AA) unit,each respectively generating PVR, OPG, PPG, and AA data signals, atleast one of said doppler data signals and said respective data signalshaving an audio characteristic, the method comprising the stepsof:electronically acquiring and converting said data signals into aninitial set of digital data signals; compiling and initially storingsaid initial set of digital data signals into a data base, said initialstorage of said initial set of digital data occurring substantiallyconcurrently with the acquisition of said instrument data signals;generating and displaying, at a time subsequent to said initial digitaldata storage and not during data acquisition, and producing a pluralityof vascular diagnostic reports based upon said digital data, at least aportion of said display including the display of analog representationsof said digital data, the step of generating including the step ofselecting a portion of said initial set of digital data, representing atleast one of said doppler data and said respective data, andsubsequently storing said portion of digital data as part of saidvascular diagnostic reports; and presenting both a visual analog versionof said initial set of digital data signals and an audio analog versionof said initial set of digital data signals having said audiocharacteristic substantially during to the step of selecting.
 38. Amethod as claimed in claim 37, including the step of audibly presentinganalog representations of digital data simultaneous with the visualdisplay of said digital data.
 39. A method as claimed in claim 38,including the step of reorganizing said data into a plurality ofelectronic output forms which represent said vascular diagnosticreports.
 40. A method as claimed in claim 39, including the step ofelectronically transmitting said vascular diagnostic reports and saiddigital data outbound from said vascular diagnostic system.
 41. A methodas claimed in claim 37, including the step of scrolling through saidinitial set of digital data signals during the step of selecting.
 42. Amethod as claimed in claim 37, including the step of prompting an inputof at least one of said doppler data signals and said respective datasignals.
 43. A method as claimed in claim 37, including the step ofaudibly announcing said audio analog version of said initial set ofdigital data signals having said audio characteristic into an ambientenvironment during the step of presenting.